MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Reocclusion (1985); Pain (1994); Stenosis (2263); Claudication (2550); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Patient identifier: (b)(6).

Event Description

(b)(6) clinical study.It was reported that stenosis occurred.The patient was enrolled in the (b)(6) clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa) involving ppa with 99% stenosis and with a 5mm reference vessel diameter proximally and distally and was classified as tasc ii b lesion.The lesion length was 80mm.Pre-dilation was performed and 6 x 100mm study stent was implanted.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, during protocol scheduled 36 months follow up visit, the subject was noted with symptoms of pain and claudication in the left leg.No action was taken during the follow up visit.On (b)(6) 2020, the subject was hospitalized for further evaluation.On (b)(6) 2020, an unknown percentage of stenosis in left proximal, mid and distal sfa involving ppa was treated with percutaneous transluminal angioplasty and drug coated balloon.

Event Description

Eminent clinical study it was reported that stenosis occurred.The patient was enrolled in the eminent clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa) involving ppa with 99% stenosis and with a 5mm reference vessel diameter proximally and distally and was classified as tasc ii b lesion.The lesion length was 80mm.Pre-dilation was performed and 6x100mm study stent was implanted.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, during protocol scheduled 36 months follow up visit, the subject was noted with symptoms of pain and claudication in the left leg.No action was taken during the follow up visit.On (b)(6) 2020, the subject was hospitalized for further evaluation.On (b)(6) 2020, an unknown percentage of stenosis in left proximal, mid and distal sfa involving ppa was treated with percutaneous transluminal angioplasty and drug coated balloon.It was further reported that on (b)(6) 2020, the subject developed left leg claudication with symptoms of pain.The subject was hospitalized for further treatment and evaluation on the same day.On (b)(6) 2020, the 50% stenosis in left ostial to distal sfa involving ppa which was 200 mm long with a proximal reference vessel diameter of 6 mm was treated with percutaneous transluminal angioplasty was performed with drug eluting balloon, resulting in 10% residual stenosis.On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day in a good general state with aspirin and clopidogrel.

Manufacturer Narrative

A1- patient identifier: (b)(6).

Manufacturer Narrative

A1- patient identifier: (b)(6).

Event Description

Eminent clinical study.It was reported that stenosis occurred.The patient was enrolled in the eminent clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa) involving ppa with 99% stenosis and with a 5mm reference vessel diameter proximally and distally and was classified as tasc ii b lesion.The lesion length was 80mm.Pre-dilation was performed and 6x100mm study stent was implanted.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, during protocol scheduled 36 months follow up visit, the subject was noted with symptoms of pain and claudication in the left leg.No action was taken during the follow up visit.On (b)(6) 2020, the subject was hospitalized for further evaluation.On may 8, 2020, an unknown percentage of stenosis in left proximal, mid and distal sfa involving ppa was treated with percutaneous transluminal angioplasty and drug coated balloon.It was further reported that on (b)(6) 2020, the subject developed left leg claudication with symptoms of pain.The subject was hospitalized for further treatment and evaluation on the same day.On (b)(6) 2020, the 50% stenosis in left ostial to distal sfa involving ppa which was 200 mm long with a proximal reference vessel diameter of 6 mm was treated with percutaneous transluminal angioplasty was performed with drug eluting balloon, resulting in 10% residual stenosis.On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day in a good general state with aspirin and clopidogrel.It was further reported that on (b)(6) 2020, the subject presented with recurrent symptoms of claudication of the left leg.The subject also complained of tingling sensations in both feet.Pre-operative ankle-brachial index at posterior tibial artery was 0.74.On (b)(6) 2020, the vessel was treated with stenting to the left common iliac artery between the 2 stents that had already been placed with dynamic 9mm x 25 mm following that, percutaneous transluminal angioplasty was performed with ranger 6 mm x 200 mm drug eluting balloon to treat in-stent claudication of left sfa in continuation dilatation of the left popliteal artery with admiral xtreme 4 mm x 20 mm balloon, resulting in 10% residual stenosis.Post-operative ankle-brachial index at posterior tibial artery was 0.72.

Event Description

Eminent clinical study: it was reported that stenosis occurred.The patient was enrolled in the eminent clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa) involving ppa with 99% stenosis and with a 5mm reference vessel diameter proximally and distally and was classified as tasc ii b lesion.The lesion length was 80mm.Pre-dilation was performed and 6x100mm study stent was implanted.Following post dilation, residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, during protocol scheduled 36 months follow up visit, the subject was noted with symptoms of pain and claudication in the left leg.No action was taken during the follow up visit.On (b)(6) 2020, the subject was hospitalized for further evaluation.On (b)(6) 2020, an unknown percentage of stenosis in left proximal, mid and distal sfa involving ppa was treated with percutaneous transluminal angioplasty and drug coated balloon.It was further reported that on (b)(6) 2020, the subject developed left leg claudication with symptoms of pain.The subject was hospitalized for further treatment and evaluation on the same day.On (b)(6) 2020, the 50% stenosis in left ostial to distal sfa involving ppa which was 200 mm long with a proximal reference vessel diameter of 6 mm was treated with percutaneous transluminal angioplasty was performed with drug eluting balloon, resulting in 10% residual stenosis.On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day in a good general state with aspirin and clopidogrel.It was further reported that on (b)(6) 2020, the subject presented with recurrent symptoms of claudication of the left leg.The subject also complained of tingling sensations in both feet.Pre-operative ankle-brachial index at posterior tibial artery was 0.74.On (b)(6) 2020, the vessel was treated with stenting to the left common iliac artery between the 2 stents that had already been placed with dynamic 9mm x 25 mm following that, percutaneous transluminal angioplasty was performed with ranger 6 mm x 200 mm drug eluting balloon to treat in-stent claudication of left sfa in continuation dilatation of the left popliteal artery with admiral xtreme 4 mm x 20 mm balloon, resulting in 10% residual stenosis.Post-operative ankle-brachial index at posterior tibial artery was 0.72.It was further reported that on (b)(6) 2020, the subject presented with recurrent symptoms of claudication of the left leg not on (b)(6) 2020 as previously reported.The subject also complained of tingling sensations in both feet, possibly in the context of parkinsons.On (b)(6) 2020, the 50% stenosis in left ostial to distal sfa involving ppa which was 200 mm long with a proximal reference vessel diameter of 6 mm was treated with percutaneous transluminal angioplasty using 6 mm x 200 mm ranger drug eluting balloon.Further, dilatation of the left popliteal artery was performed with 4 mm x 20 mm admiral xtreme balloon.The (b)(6) 2020 date was previously reported as (b)(6) 2020.At the time of procedure, left common iliac artery was treated with 9 mm x 25 mm dynamic stent, which was implanted between the 2 previously placed stents.Post procedural revealed 10% residual stenosis in the distal sfa involving ppa.Subject was recommended to take lifelong treatment with asaflow 80mg including clopidogrel 75mg for 3 months prophylactically secondary thrombosis.Additionally, clexane was discontinued.On (b)(6) 2020, the event was considered recovered/resolved and the subject was discharged on the same day not on (b)(6) 2020 as previously reported.

Manufacturer Narrative

A1: patient identifier: (b)(6).

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10108996
• MDR Text Key: 193323893
• Report Number: 2134265-2020-07315
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019631128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR